Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
Official title:
A Phase I Study of High Dose Topotecan With Filgrastim and Peripheral Blood Stem Cell Support for Patients With Refractory Malignancies
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Combining chemotherapy with peripheral stem cell
transplantation may allow the doctor to give higher doses of drugs and kill more tumor
cells.
PURPOSE: Phase I trial to study the effectiveness of high-dose topotecan and peripheral stem
cell transplantation in treating patients with refractory cancer.
OBJECTIVES:
- Determine the maximum tolerated dose, toxicities, and preliminary antitumor activity of
escalating doses of topotecan, with filgrastim (G-CSF) and peripheral blood stem cell
support, when administered to patients with refractory malignancies for which no
effective therapy exists.
OUTLINE: This is a dose-escalation study.
Prior to stem cell harvesting, patients receive 1-2 courses of mobilizing salvage
chemotherapy.
After stem cell harvest, high-dose topotecan is administered according to an escalating
dosage scale. Topotecan is given over 30 minutes daily for three days. A minimum of 3
patients are entered at each dose level. The MTD is defined as the dose immediately below
that at which 2 patients experience dose limiting toxicity.
Peripheral blood stem cells (PBSC) are infused at least 24 hours after treatment with
topotecan is complete. Filgrastim (G-CSF) is administered subcutaneously beginning on the
day PBSC are infused and continuing until blood counts recover.
Patients are followed every 3 months for 1 year and then every 6 months thereafter.
PROJECTED ACCRUAL: Not specified
;
Primary Purpose: Treatment
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